Discover and read the best of Twitter Threads about #BharatBiotech
Most recents (16)
Today was the first appearance of India’s #DCGI on a public platform after the WHO suspended the supply of #BharatBiotech’s #Covaxin to UN due to quality issues it found in its manufacturing practises, in March this year (1/n)
It was at @CPR_India dialogues series where the discussion was happening about regulation of various health aspects in India. I asked him ( at 1.01.20) since WHO had already submitted the inspection report; also the Bharat Biotech’s corrective plan and
WHO’s rejection of it, would he divulge the key findings of both reports (submitted in Apr and Jul) and since this was the issue of larger public interest, would he like to put these reports in public domain?
Though #BharatBiotech is now waiting to launch an all new intranasal vaccine against #Covid_19 pending regulator's nod, its problems with #Covaxin are still far from over ever since #WHO suspended its supply for UN agencies in April (1/n) science.thewire.in/health/exclusi…
It's 4 months into suspension already but WHO is still not satisfied with company's good manufacturing practises (GMPs), it told me last Friday, sharing its assessment of corrective and preventive action (CAPA) plan submitted by company in June. Here's what the WHO exactly said:
"In summary, based on the said CAPA response, the manufacturing site for Covaxin is still considered to be operating at an unacceptable level of compliance with WHO Good Manufacturing Practices for Pharmaceutical Products guidelines,"
The #WHO on April 2 issued a statement saying the supply of #Covaxin to UN agencies had been suspended due to "deficiencies in good manufacturing practices". There were not mny details. In an email, they have now told @TheWireScience the following : science.thewire.in/health/who-cov… (1/n)
"Problems were detected in some parts of the manufacturing process. SOME CHANGES WERE MADE after the emergency-use license was granted but were not submitted to the national drug regulator and WHO for evaluation and validation."
The WHO still didn't specify what were those changes. Whether those changes were related to increase the yield, or on the front of raw materials or due to some other reason--we don't know. A GMP expert said major changes, if done post approval, have to be informed.
Just in: Padma Awards, one of the highest civilian Awards of the country, have been announced. CDS #BipinRawat given #PadmaVibhushan posthumously, @vijaita reports.
@vijaita
#KalyanSingh posthumous receives the Padma Vibhushan, while Congress’ #GhulamNabiAzad, CPI-M’s #BuddhadebBhattacharjee get Padma Bhushan, @vijaita reports.
#KalyanSingh posthumous receives the Padma Vibhushan, while Congress’ #GhulamNabiAzad, CPI-M’s #BuddhadebBhattacharjee get Padma Bhushan, @vijaita reports.
@vijaita
#BharatBiotech’s Krishna Ella and Suchitra Ella, #CyrusPoonawalla of Serum Institute of India get Padma Bhushan, @vijaita reports.
#BharatBiotech’s Krishna Ella and Suchitra Ella, #CyrusPoonawalla of Serum Institute of India get Padma Bhushan, @vijaita reports.
#BigStory
The Brazilian government’s deal to import 20 million doses of Bharat Biotech’s Covaxin has sparked an investigation into corruption—raising questions about the involvement of President #Bolsonaro and about the vaccine itself.
The Brazilian government’s deal to import 20 million doses of Bharat Biotech’s Covaxin has sparked an investigation into corruption—raising questions about the involvement of President #Bolsonaro and about the vaccine itself.
In a deal signed in February, the Brazilian Health ministry agreed to pay $320 million for 20 million doses of Covaxin—at an eye-watering price of $15 per dose. The agreement was signed with a ‘middleman’ company called Precisa Medicamentos.
Bolsonaro’s mishandling of the pandemic is currently being investigated by a parliamentary commission. 2 big government contracts—one to buy Covaxin and the other to purchase raw materials for the drug Hydroxychloroquine—have raised a lot of red flags.
India's 1st coronavirus vaccine for kids could be ready by September, said Dr. Randeep Guleria, AIIMS chief said. "COVAXIN's data for children after completion of Phase 2/3 trials will be available by September, approval is expected the same month."
newsbytesapp.com/news/india/cov…
newsbytesapp.com/news/india/cov…
For context, AIIMS-Delhi had this month started screening children for the clinical trials of COVAXIN. A week before that, AIIMS-Patna had begun this jab's clinical trials on children. #AIIMS #clinicaltrial
Further, #BharatBiotech, which developed this vaccine, had last month obtained permission from the Drugs Controller General of India to carry out its trials on children. COVAXIN is India's only fully indigenous COVID-19 jab so far. #DCGI
Why are engineers and technologists running vaccination in #india @drharshvardhan @PMOIndia ? The #cowin portal leads to exclusion of those who don't have smart phones, aren't tech savvy, are women, have data packs. Don't you see ground realities before coming out with policies?
Also please refer us to the official document which is not an FAQ that mandates #cowin for vaccination
Until recently #cowin was only available in English. India isn't Bangalore.
The only rationale I can see from this arbitrary decision is to force citizens going to Private Centres (PVCs) to pay the new price (₹600 for covishield and ₹1200 for covaxin). (1/n)
ndtv.com/india-news/pri…
ndtv.com/india-news/pri…
Returning stocks, auditing them, and then reissuing them to state govt providers (SVCs) is a time-consuming process and an utter waste of resources. These 'unused vax' could instead be used to inoculate other eligible populations (18+, second dose for 45+, FLW, HCW, etc) (2/n)
Basically, the central govt is telling citizens that, post 30th April, PVCs will not be able to give jabs @ ₹150 as they were giving before. They'll have to charge full price as decided by #SII and #BharatBiotech (₹600 and ₹1200, respectively).
(3/n)
(3/n)
1. Absolutely Shocking #PfizerTerror
Pfizer threatens govts for Vaccines, interferes with legislation, demands Military basis as guarantee.
Here's what happened..
Pfizer threatens govts for Vaccines, interferes with legislation, demands Military basis as guarantee.
Here's what happened..
2. Pfizer has deals with most latin American countries Chile, Costa rica, Mexico, Columbia, peru, Ecuador, panama & Uruguay except Argentina & Brazil.
Pfizer came to Argentina in June 2020 for vaccine deal. But they asked to be compensated for any future law suits.
Pfizer came to Argentina in June 2020 for vaccine deal. But they asked to be compensated for any future law suits.
3. Which means if anyone files lawsuit against Pfizer & wins, the Pfizer will not pay the compensation but Govt of Argentina has to pay.
But govt rejected & asked it to bear the cost of negligence for which Pfizer refused & told Govt to get international insurance.
But govt rejected & asked it to bear the cost of negligence for which Pfizer refused & told Govt to get international insurance.
#ModiHaiTohMumkinHai
Thread-Vacine drama
Why US banned raw material export to India 1st?
Why now suddenly they agreed to help?
Man behind it- #NarendraModi, a leader who knows how to,Silently. The one who perform best under pressure&is master of diplomacy.
#vaccination
1/n
Thread-Vacine drama
Why US banned raw material export to India 1st?
Why now suddenly they agreed to help?
Man behind it- #NarendraModi, a leader who knows how to,Silently. The one who perform best under pressure&is master of diplomacy.
#vaccination
1/n
Since start of India's #VaccinationDrive ,India was emerging a global leader in #VaccineDiplomacy .
India under its Vaccine Maitri campaign started shipping its Made in India #CovishieldVaccine to world.
Till now India has provided its vaccine to more than 90 countries.
2/n
India under its Vaccine Maitri campaign started shipping its Made in India #CovishieldVaccine to world.
Till now India has provided its vaccine to more than 90 countries.
2/n
B4 Covid-19 vaccines were developed,India supplied some 100 countries with hydroxychloroquine& paracetamol,and sent pharmaceuticals,test kits&other equipment to around 90 countries.India was emerging as global pharmaceutical powerhouse&#Modiji as powerfull leader.
3/n
3/n
Merck takes distance; you don't want to embark on a possible genocide.
Ken Frazier, CEO of the world's leading vaccine producer, the pharmaceutical company Merck & Co., in an interview with Professor Tsedal Neeley, from Harvard Business School, recalled that the fastest vaccine
Ken Frazier, CEO of the world's leading vaccine producer, the pharmaceutical company Merck & Co., in an interview with Professor Tsedal Neeley, from Harvard Business School, recalled that the fastest vaccine
ever brought to market was medicine. from Merck against mumps, it took about four years!
- Merck's vaccine for Ebola took five and a half years and was only approved in Europe this month.
- The tuberculosis vaccine took 13 years! Rotavirus 15 years! and chickenpox 28 years !
- Merck's vaccine for Ebola took five and a half years and was only approved in Europe this month.
- The tuberculosis vaccine took 13 years! Rotavirus 15 years! and chickenpox 28 years !
- Frazier explained that the vaccine development process takes a long time because it requires rigorous scientific evaluation. In the case of Covid, "we don't even understand the virus itself or how the virus affects the immune system ..."
My analysis of the paper released by #BharatBiotech researchers & the Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of 1out of 3 COVID-19 virus vaccine from Bharat Biotech: A thread...
1. PIB "The Phase III efficacy trial was initiated in India in 25,800 volunteers & till date, ~22,500 participants have been vaccinated across the country"
Fact check "A total of 25,800 subjects will be enrolled & randomized in a 1:1 ratio to receive BBV152B vaccine and control"
Fact check "A total of 25,800 subjects will be enrolled & randomized in a 1:1 ratio to receive BBV152B vaccine and control"
1. Fact check contd...
A 1:1 ratio means half of 25800 will be enrolled, of which only (almost) 12900 will be given BBV152B vaccine and the other 12900 will be given a placebo, i.e. Phosphate buffered saline PBS with Alum gel (without antigen)
Source: CTRI
A 1:1 ratio means half of 25800 will be enrolled, of which only (almost) 12900 will be given BBV152B vaccine and the other 12900 will be given a placebo, i.e. Phosphate buffered saline PBS with Alum gel (without antigen)
Source: CTRI
Memo
Re Bharat Biotech Covaxin.
1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy.
2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Re Bharat Biotech Covaxin.
1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy.
2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Memo (continued)
3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
4. We should no more accept an opaque regulatory process that we would accept a kangaroo court that delivers its verdict in a closed court.
"It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.": tweets PM Modi
#CovidVaccine | #DCGI granting approval to vaccines of #SerumInstituteofIndia and #BharatBiotech accelerates the road to COVID-free nation: PM Modi
(PTI)
(PTI)
#CovidVaccine | India's drugs regulator approves #Oxford's #COVID19vaccine #Covishield and Bharat Biotech's #Covaxin for restricted emergency use
(PTI)
(PTI)
Watch LIVE: Press Briefing by @MoHFW_INDIA on the actions taken, preparedness, and updates on #COVID19
In 14 States total number of active cases less than 5,000 : @MoHFW_INDIA
1)India’s Covaxin may not be Indian enough, or worse!
Bharat Biotech (BB) announced that it had developed a vaccine against the novel coronavirus, named Covaxin, together with the Indian Council of Medical Research (ICMR) and
#BharatBiotech #Covaxin
science.thewire.in/health/how-ind…
Bharat Biotech (BB) announced that it had developed a vaccine against the novel coronavirus, named Covaxin, together with the Indian Council of Medical Research (ICMR) and
#BharatBiotech #Covaxin
science.thewire.in/health/how-ind…
2)National Institute of Virology (NIV), Pune.The company had also received permission from the Drug Controller General of India (DCGI) to begin human trials.
ICMR transferred the strain NIV had isolated to Biotech Bharat on May 9.
#NationalInstituteofVirology
ICMR transferred the strain NIV had isolated to Biotech Bharat on May 9.
#NationalInstituteofVirology
3)The company published its press release on June 29. There were only 50 days in between, during which the company would have developed the inactivated vaccine, conducted pre clinical animal trials (with mice and hamsters),
ndtv.com/india-news/cor…
ndtv.com/india-news/cor…
